Prescription drug · NDA AUTHORIZED GENERIC
Atovaquone and Proguanil HCl NDC 66993-060
atovaquone and proguanil hydrochloride · Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-060-02 | 66993006002 | 100 TABLET, FILM COATED in 1 BOTTLE (66993-060-02)Marketed from Jul 27, 2012 | |
| 66993-060-27 | 66993006027 | 24 TABLET, FILM COATED in 1 DOSE PACK (66993-060-27)Marketed from Jul 27, 2012 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Atovaquone and Proguanil HCl
- Generic name (nonproprietary)
- atovaquone and proguanil hydrochloride
- Active ingredients
- Atovaquone — 250 mg/1Proguanil hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021078
- Marketing start
- Listing expires
- Other FDA classes
- Dihydrofolate Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 66993-060_9e28a4ce-4524-4921-902c-7cc939eea6b5SPL ID 9e28a4ce-4524-4921-902c-7cc939eea6b5SPL set ID 7069521a-c7f9-4e8d-99b8-0cb5c971e7cfRxCUI 864675UNII Y883P1Z2LT, R71Y86M0WTUPC 0366993060026
- Pharmacologic class
- Antimalarial; Antiprotozoal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N466993006002followed by a unit qualifier and the quantityPackage 66993-0060-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Atovaquone and Proguanil Hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride have been shown to be effectiv…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021078
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2980 |
| Malaroneatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0675 |
| Malaroneatovaquone and proguanil hydrochloride | Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0676 |